Newly appointed Elizabeth Barrett, who less than a week ago took the helm as UroGen’s (URGN)
president and CEO, discussed the company’s uro-oncology-focused pipeline, mostly highlighting
lead candidate UGN-101 (mitomycin gel), which has FDA Fast-Track, Breakthrough, and Orphan
designations for low-grade upper tract urothelial cancer (LG UTUC; a rare malignant cancer of the
cells lining the urinary tract, which affects a US patient population of about 6-8k). Because LG
UTUC most commonly presents in the elderly, who often have co-morbidities, and the current
standard of care in 78% of the cases requires kidney and/or ureter removal surgery, Ms. Barrett
emphasized the advantage of a non-surgical treatment option.
president and CEO, discussed the company’s uro-oncology-focused pipeline, mostly highlighting
lead candidate UGN-101 (mitomycin gel), which has FDA Fast-Track, Breakthrough, and Orphan
designations for low-grade upper tract urothelial cancer (LG UTUC; a rare malignant cancer of the
cells lining the urinary tract, which affects a US patient population of about 6-8k). Because LG
UTUC most commonly presents in the elderly, who often have co-morbidities, and the current
standard of care in 78% of the cases requires kidney and/or ureter removal surgery, Ms. Barrett
emphasized the advantage of a non-surgical treatment option.
The company recently announced positive results of UGN-101 from the ongoing pivotal Phase III
OLYMPUS trial in which 57% patients achieved a complete response rate, all of whom were
evaluated remained disease free at 6 months. In December, the company initiated a rolling
submission for FDA approval, which is anticipated in the first half of 2020. UGN-101, as well as
UroGen’s two other uro-oncology pipeline candidates (UGN-102 and UGN-201), are driven by
UroGen’s RTGel sustained release, hydrogel-based formulation platform; a reverse thermal gel
that liquefies upon instillation at body temperature, enabling longer exposure of mitomycin to
urinary tract tissue, thereby providing a non-surgical tumor treatment option. Both for bladder
cancer, UGN-102 addresses a low-grade non-muscle invasive bladder cancer (NMIBC) US patient
population of about 80k, while UGN-201, for the high-grade form of the disease (CIS; carcinoma
in situ), addresses a US market of about 2k patients. For UGN-102, a Phase IIb trial in NMIBC was
initiated in August 2018 with interim data expected during 1H 2019. Phase Ib data for UGN-201 in
CIS suggests preliminary efficacy with the company evaluating future clinical trials.
An additional candidate, BotuGel, is partnered via a 2016 deal potentially worth up to $225m
with Allergan, which is using the RTGel platform with its neurotoxins to treat overactive bladder.
Phase II data is expected in 2H 2019. The potential applications of the RTGel platform, including
other UTUC and bladder cancer uses, as well as gastroenterology, women’s health, weight loss,
and enteral feeding indications, were also highlighted. Ms. Barrett closed the presentation
stressing that 2019 will be a defining year for UroGen on the eve of the anticipated
commercialization of its first product (UGN-101) in 2020.
OLYMPUS trial in which 57% patients achieved a complete response rate, all of whom were
evaluated remained disease free at 6 months. In December, the company initiated a rolling
submission for FDA approval, which is anticipated in the first half of 2020. UGN-101, as well as
UroGen’s two other uro-oncology pipeline candidates (UGN-102 and UGN-201), are driven by
UroGen’s RTGel sustained release, hydrogel-based formulation platform; a reverse thermal gel
that liquefies upon instillation at body temperature, enabling longer exposure of mitomycin to
urinary tract tissue, thereby providing a non-surgical tumor treatment option. Both for bladder
cancer, UGN-102 addresses a low-grade non-muscle invasive bladder cancer (NMIBC) US patient
population of about 80k, while UGN-201, for the high-grade form of the disease (CIS; carcinoma
in situ), addresses a US market of about 2k patients. For UGN-102, a Phase IIb trial in NMIBC was
initiated in August 2018 with interim data expected during 1H 2019. Phase Ib data for UGN-201 in
CIS suggests preliminary efficacy with the company evaluating future clinical trials.
An additional candidate, BotuGel, is partnered via a 2016 deal potentially worth up to $225m
with Allergan, which is using the RTGel platform with its neurotoxins to treat overactive bladder.
Phase II data is expected in 2H 2019. The potential applications of the RTGel platform, including
other UTUC and bladder cancer uses, as well as gastroenterology, women’s health, weight loss,
and enteral feeding indications, were also highlighted. Ms. Barrett closed the presentation
stressing that 2019 will be a defining year for UroGen on the eve of the anticipated
commercialization of its first product (UGN-101) in 2020.
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